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两种用于急性术后疼痛管理的非侵入性患者自控镇痛治疗的间接治疗比较。

Indirect treatment comparison of two non-invasive patient-controlled analgesia treatments for acute post-operative pain management.

作者信息

Katz Pablo, Takyar Shweta, Palmer Pamela, Liedgens Hiltrud

机构信息

a Grünenthal GmbH , Aachen , Germany.

b Parexel International , Chandigarh , UT , India.

出版信息

Curr Med Res Opin. 2017 May;33(5):911-918. doi: 10.1080/03007995.2017.1294560. Epub 2017 Mar 15.

Abstract

OBJECTIVES

To evaluate the relative clinical efficacy, safety, and tolerability associated with two non-invasive patient-controlled analgesia (PCA) treatments, sufentanil sublingual tablet system (SSTS) and fentanyl iontophoretic patient-controlled transdermal system (PCTS). These two treatments have recently been approved in the EU for the management of acute moderate-to-severe post-operative pain in adult patients.

METHODS

As no head-to-head trials comparing SSTS and PCTS currently exist, indirect treatment comparison (ITC) analyses were conducted to evaluate SSTS or PCTS versus intravenous (IV) morphine PCA.

RESULTS

Five studies, four assessing PCTS and one assessing SSTS, were included in this analysis. SSTS had statistical or numerical advantages over PCTS for both patient global assessment (PGA) and healthcare professional global assessment (HPGA) outcomes at all time points investigated. SSTS was also associated with greater patient ease of use (weighted mean difference [WMD]: 0.13; 95% confidence interval [CI]: -0.02-0.28) and a higher patient satisfaction score (WMD: 0.31; 95% CI: 0.05-0.57; p = .019) compared with PCTS. In terms of tolerability, all-cause withdrawals from treatment were reported to be less likely with SSTS (risk ratio: 0.65; 95% CI: 0.42-1.02). No significant differences were observed between SSTS and PCTS in terms of safety and adverse events.

CONCLUSIONS

In the absence of direct head-to-head data, the combination of promising phase III trial results compared to IV morphine PCA, a SLR comparison against other opioid treatments, and the results of this exploratory analysis present a strong rationale in support of SSTS as a key option for management of post-operative pain.

摘要

目的

评估两种非侵入性患者自控镇痛(PCA)治疗方法,即舒芬太尼舌下片系统(SSTS)和芬太尼离子导入患者自控透皮系统(PCTS)的相对临床疗效、安全性和耐受性。这两种治疗方法最近已在欧盟获批用于管理成年患者的急性中重度术后疼痛。

方法

由于目前不存在比较SSTS和PCTS的直接对比试验,因此进行了间接治疗比较(ITC)分析,以评估SSTS或PCTS与静脉注射(IV)吗啡PCA的疗效。

结果

本分析纳入了五项研究,四项评估PCTS,一项评估SSTS。在所有研究的时间点,SSTS在患者整体评估(PGA)和医疗专业人员整体评估(HPGA)结果方面均比PCTS具有统计学或数值上的优势。与PCTS相比,SSTS还具有更高的患者易用性(加权平均差[WMD]:0.13;95%置信区间[CI]:-0.02-0.28)和更高的患者满意度评分(WMD:0.31;95%CI:0.05-0.57;p = 0.019)。在耐受性方面,据报道SSTS导致的全因治疗中断可能性较小(风险比:0.65;95%CI:0.42-1.02)。SSTS和PCTS在安全性和不良事件方面未观察到显著差异。

结论

在缺乏直接对比数据的情况下,与IV吗啡PCA相比有前景的III期试验结果、与其他阿片类药物治疗的系统评价对比,以及本探索性分析的结果,为支持SSTS作为术后疼痛管理的关键选择提供了有力依据。

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